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Efficacy and tolerability of gastric-retentive gabapentin for the treatment of postherpetic neuralgia: results of a double-blind, randomized, placebo-controlled clinical trial.
Clin J Pain 2009 Mar-Apr; 25(3):185-92CJ

Abstract

OBJECTIVE

To determine the efficacy and safety of a gastric-retentive, extended-release gabapentin (gabapentin ER) taken once or twice daily for treatment of postherpetic neuralgia.

METHODS

Using an enrichment design, a randomized, double-blind, placebo-controlled study was conducted in 158 patients who had experienced pain for at least 3 months after healing of acute herpes zoster skin rash and who had a baseline average daily pain (ADP) score of > or =4 on a 0 to 10 Numerical Rating Scale. Patients received gabapentin ER either once daily (1800 mg PM) or twice daily (600 mg AM, 1200 mg PM) or placebo for 4 weeks. Efficacy measures included changes from baseline to end point in ADP score and average daily sleep interference score.

RESULTS

Mean (SEM) changes for ADP score were -1.93 (0.28), -2.24 (0.29), and -1.29 (0.29) in the gabapentin ER once daily, twice daily, and placebo groups, respectively (P=0.089 and 0.014 for gabapentin ER once daily and twice daily, respectively, vs. placebo), with 25.5%, 28.8%, and 11.8% of patients, respectively, reporting > or =50% decrease from baseline in ADP score. Mean (SEM) changes in sleep interference scores were -1.94 (0.30), -2.28 (0.30), and -1.16 (0.30), respectively (P=0.048 and 0.006 for gabapentin ER once daily and twice daily, respectively, vs. placebo). Common adverse events in the gabapentin ER once daily, twice daily, and placebo groups, respectively, were dizziness (22.2%, 11.3%, and 9.8%) and somnolence (9.3%, 7.5%, and 7.8%).

CONCLUSIONS

Gabapentin ER administered twice daily is effective and safe for the treatment of pain associated with postherpetic neuralgia.

Authors+Show Affiliations

Swedish Pain and Headache Center, Seattle, WA 98104, USA. gordon.irving@swedish.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19333167

Citation

Irving, Gordon, et al. "Efficacy and Tolerability of Gastric-retentive Gabapentin for the Treatment of Postherpetic Neuralgia: Results of a Double-blind, Randomized, Placebo-controlled Clinical Trial." The Clinical Journal of Pain, vol. 25, no. 3, 2009, pp. 185-92.
Irving G, Jensen M, Cramer M, et al. Efficacy and tolerability of gastric-retentive gabapentin for the treatment of postherpetic neuralgia: results of a double-blind, randomized, placebo-controlled clinical trial. Clin J Pain. 2009;25(3):185-92.
Irving, G., Jensen, M., Cramer, M., Wu, J., Chiang, Y. K., Tark, M., & Wallace, M. (2009). Efficacy and tolerability of gastric-retentive gabapentin for the treatment of postherpetic neuralgia: results of a double-blind, randomized, placebo-controlled clinical trial. The Clinical Journal of Pain, 25(3), pp. 185-92. doi:10.1097/AJP.0b013e3181934276.
Irving G, et al. Efficacy and Tolerability of Gastric-retentive Gabapentin for the Treatment of Postherpetic Neuralgia: Results of a Double-blind, Randomized, Placebo-controlled Clinical Trial. Clin J Pain. 2009;25(3):185-92. PubMed PMID: 19333167.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of gastric-retentive gabapentin for the treatment of postherpetic neuralgia: results of a double-blind, randomized, placebo-controlled clinical trial. AU - Irving,Gordon, AU - Jensen,Mark, AU - Cramer,Marilou, AU - Wu,Jacqueline, AU - Chiang,Yu-Kun, AU - Tark,Marvin, AU - Wallace,Mark, PY - 2009/4/1/entrez PY - 2009/4/1/pubmed PY - 2009/6/26/medline SP - 185 EP - 92 JF - The Clinical journal of pain JO - Clin J Pain VL - 25 IS - 3 N2 - OBJECTIVE: To determine the efficacy and safety of a gastric-retentive, extended-release gabapentin (gabapentin ER) taken once or twice daily for treatment of postherpetic neuralgia. METHODS: Using an enrichment design, a randomized, double-blind, placebo-controlled study was conducted in 158 patients who had experienced pain for at least 3 months after healing of acute herpes zoster skin rash and who had a baseline average daily pain (ADP) score of > or =4 on a 0 to 10 Numerical Rating Scale. Patients received gabapentin ER either once daily (1800 mg PM) or twice daily (600 mg AM, 1200 mg PM) or placebo for 4 weeks. Efficacy measures included changes from baseline to end point in ADP score and average daily sleep interference score. RESULTS: Mean (SEM) changes for ADP score were -1.93 (0.28), -2.24 (0.29), and -1.29 (0.29) in the gabapentin ER once daily, twice daily, and placebo groups, respectively (P=0.089 and 0.014 for gabapentin ER once daily and twice daily, respectively, vs. placebo), with 25.5%, 28.8%, and 11.8% of patients, respectively, reporting > or =50% decrease from baseline in ADP score. Mean (SEM) changes in sleep interference scores were -1.94 (0.30), -2.28 (0.30), and -1.16 (0.30), respectively (P=0.048 and 0.006 for gabapentin ER once daily and twice daily, respectively, vs. placebo). Common adverse events in the gabapentin ER once daily, twice daily, and placebo groups, respectively, were dizziness (22.2%, 11.3%, and 9.8%) and somnolence (9.3%, 7.5%, and 7.8%). CONCLUSIONS: Gabapentin ER administered twice daily is effective and safe for the treatment of pain associated with postherpetic neuralgia. SN - 1536-5409 UR - https://www.unboundmedicine.com/medline/citation/19333167/Efficacy_and_tolerability_of_gastric_retentive_gabapentin_for_the_treatment_of_postherpetic_neuralgia:_results_of_a_double_blind_randomized_placebo_controlled_clinical_trial_ L2 - http://Insights.ovid.com/pubmed?pmid=19333167 DB - PRIME DP - Unbound Medicine ER -